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Evaluation of Three Pulp Vitality Tests

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ClinicalTrials.gov Identifier: NCT02636504
Recruitment Status : Not yet recruiting
First Posted : December 21, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date December 16, 2015
First Posted Date December 21, 2015
Last Update Posted Date June 5, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2015)
The number of teeth showing the true positive, true negative, false positive, and false negative after pulp vitality testing [ Time Frame: 1 year ]
Patients who present to the endodontic clinic for a consultation visit prior to treatment. The patient will have three types of pulp vitality tests done on the tooth that is to receive endodontic treatment. The number of teeth that show the true positive, true negative, false positive, and false negative after pulp vitality testing will be measured. For example, a tooth that is diagnosed nonvital based on the pulp vitality testing will be confirmed when endodontic treatment is performed. If there is a discrepancy, it can be counted as false negative. When a tooth is diagnosed vital based on the pulp testing and confirmed to be vital, it can be counted as true positive. When a tooth is diagnosed vital based on the pulp testing and confirmed to be nonvital, it can be counted as false positive. When a tooth is diagnosed nonvital and confirmed novital, it is counted as true negative.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02636504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Three Pulp Vitality Tests
Official Title Evaluation of Three Pulp Vitality Tests
Brief Summary The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.
Detailed Description Prior to starting any endodontic treatment, it is essential to determine the vitality of the tooth in question. Vitality of a tooth is defined as the presence of blood flow into the tooth. The vitality status of a tooth will affect the success of endodontic treatment, and therefore plays an important role in treatment planning. Two established methods of determining vitality are electric pulp tests and cold tests. However, both these methods have drawbacks. Both methods use the presence of sensory feedback in the tooth as a predictor of tooth vitality. This can lead to errors because blood flow and nerves in the tooth may be lost at different times, resulting in false-positive and false-negative responses. Both are subjective and patient-dependent, relying on the patient to indicate when pain is felt. In addition, studies have suggested that electric pulp testing and cold tests are not as reliable in immature teeth, teeth undergoing orthodontic movement, traumatized teeth, and teeth with significant secondary dentin. Laser Doppler flowmetry is a technique that utilizes the Doppler principle to determine blood flow. It has been used widely in the medical field to measure blood flow in the skin. Some studies have also shown good results in measuring blood flow in the pulp of teeth. The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients that need endodontic treatment will have a consultation visit first. In most cases, the endodontic treatment will be provided at a subsequent visit. In some cases the endodontic treatment will be provided at the same visit. Patients who present to the endodontic clinic for a consultation visit for endodontic treatment. The patient will have three types of pulp vitality tests done on the tooth that is to receive endodontic treatment.
Condition
  • Dental Pulp Diseases
  • Dental Pulp Vitality Testing
Intervention Device: Laser Doppler Flowmetry
Pulp vitality of teeth is tested with three pulp vitality testing including laser Doppler flowmetry, cold testing, and electric pulp testing.
Other Names:
  • Cold testing
  • Electric Pulp Testing
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 17, 2015)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Criteria for inclusion in the study will be that the individual has teeth that require endodontic treatment and patient is willing to undergo two additional vitality tests which will take about 20 minutes of additional time.

Exclusion Criteria:

  • No group of special subjects or vulnerable population is being targeted in this study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sahng G Kim, DDS, MS 212-305-2015 sgk2114@cumc.columbia.edu
Contact: Anshul Mainkar, BS aam2207@cumc.columbia.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02636504
Other Study ID Numbers AAAO5900
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Columbia University
Study Sponsor Columbia University
Collaborators Not Provided
Investigators
Principal Investigator: Sahng G Kim, DDS, MS Columbia University College of Dental Medicine
PRS Account Columbia University
Verification Date June 2019